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Home Based Care Transitions Tailored by Cognition and Patient Activation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Lani M. Zimmerman, BSN MSN PhD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02045147
First received: January 22, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

There is overwhelming evidence that patients with multiple chronic illnesses need better self-management skills. Discharge from the hospital may not be the most opportune time to be teaching patients these self-management skills. There are several different care transition models being used across the country; however we know that not every patient needs the same type or amount of an intervention. The purpose of this pilot study is to examine the effects of delivering a home based care transitions intervention (HBCTI) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and quality of life in adult patients with multiple chronic diseases dismissed to home from an acute care facility. Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU and improved outcomes (patient-reported health status, assessment of care for chronic conditions, and quality of life).


Condition Intervention
Chronic Disease
Behavioral: Grp 1 Low Cognition, Low Activation
Behavioral: Grp 2 Low Cognition, High Activation
Behavioral: Grp 3 Normal Cognition, Low Activation
Behavioral: Grp 4 Normal Cognition, High Activation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Based Care Transitions Tailored by Cognition and Patient Activation: A Prudent Use of Transitional Care Resources

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Health Care Utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period will be measured. Validation data will be obtained from the clinical sites.


Secondary Outcome Measures:
  • Patient reported health status. [ Time Frame: 1 month, 2 months and 6 months ] [ Designated as safety issue: No ]
    Data from the patient-reported health status (PROMIS measure), assessment of care for chronic conditions, and quality of life (EQ-5D) at 1, 2, and 6 months after discharge will be measured and compared for group differences.


Estimated Enrollment: 240
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Grp 1 Low Cognition, Low Activation
Group 1: Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention.
Behavioral: Grp 1 Low Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Other Name: SC Low Cognition, Low Activation
Experimental: Grp 2 Low Cognition, High Activation
Group 2: Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention.
Behavioral: Grp 2 Low Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Experimental: Grp 3 Normal Cognition, Low Activation
Group 3: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA.
Behavioral: Grp 3 Normal Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Experimental: Grp 4 Normal Cognition, High Activation
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach.
Behavioral: Grp 4 Normal Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Active Comparator: Grp 1 Low Cognition, Low Activation
Grp 1 Standard usual care
Behavioral: Grp 1 Low Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Other Name: SC Low Cognition, Low Activation
Active Comparator: Grp 2 Low Cognition High Activation
Grp 2 Standard usual care
Behavioral: Grp 2 Low Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Active Comparator: Grp 3 Normal Cognition Low Activation
Grp 3 Standard usual care
Behavioral: Grp 3 Normal Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Active Comparator: Grp 4 Normal Cognition High Activation
Grp 4 Standard usual care
Behavioral: Grp 4 Normal Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.

Detailed Description:

One in five Medicare patients discharged from the hospital experience readmission within 30 days. Too often, hospital readmissions result from inadequate transition from hospital to home at discharge. Care transitions are complicated because of high patient acuity, multiple comorbidities, decreased length of stay, and multiple clinician involvement increasing the number of handoffs. With decreased length of stay, many patients do not comprehend or feel confident with instructions for discharge, thus management of their chronic illnesses are difficult. Most formal care transition programs are standardized and every patient receives similar strategies or interventions. However, it has been well documented that patients with cognitive problems and decreased activation are at high risk for re-hospitalization related to impaired self-management. We believe that assessment of cognition and patient activation during the patient's hospitalization will provide valuable information for discharge interventions. Data related to cognition and activation can be used to tailor discharge planning and help determine what type and how many resources are needed for individual patients after hospital discharge. The purpose of this feasibility study is to examine the effects of delivering a home based care transitions intervention (HBCTI) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and quality of life in adult patients with multiple chronic diseases discharged to home from the hospital.

We will test our intervention with the following aims: Aim 1.To evaluate the effects of HBCTI on health care utilization. We will measure HCU (number of ED visits, number of unplanned clinic visits, and number of readmissions) at 1, 2, and 6 months after discharge. Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU over time (at 1, 2 and 6 months); Aim 2. To evaluate the effects of HBCTI on the following health outcomes: patient-reported health status (PROMIS-29), assessment of care for chronic conditions (PACIC), and quality of life (EuroQol). Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have improved patient-reported health status, assessment of care for chronic conditions, and quality of life (EuroQol) at 1, 2, and 6 months after discharge.

The findings from this study have the potential to change this paradigm in three ways: 1) we will gain a better understanding of the role of cognition and patient activation in promoting self-management to enhance outcomes; 2). our innovative approach, which considers the unique needs of patients based on their level of cognition and patient activation will advance new concepts in care transition programs; 3) we will have a better understanding of varying intensities of visits, level of providers, and type and amount of strategies administered. This practical model for care transitions could serve as a model within the larger health care delivery system that could result in significant cost savings.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Patients (age 19 and older) being discharged from the hospital with three or more chronic diseases;
  • Have a score greater than 17 on the Montreal Cognitive Assessment (dementia);
  • Reside within a 35 mile radius of Lincoln, Ne.; and
  • Able to hear, speak and read English.

Exclusion Criteria:

Patients will be excluded if they:

  • have a terminal illness;
  • have a score of less than 17 on the Montreal Cognitive Assessment (dementia);
  • are under the care of The Physicians Network (TPN) at St. Elizabeth Regional Medical Center (SERMC).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045147

Contacts
Contact: Lani M Zimmerman, PhD 402-472-3847 lzimmerm@unmc.edu
Contact: Myra S Schmaderer, MSN 402-472-7335 mschmade@unmc.edu

Locations
United States, Nebraska
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Elizabeth Raetz, MSN    402-219-8000    lraetz@stez.org   
Sub-Investigator: Libby Raetz, MSN         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Lani M Zimmerman, PhD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Lani M. Zimmerman, BSN MSN PhD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT02045147     History of Changes
Other Study ID Numbers: 336-13-EP
Study First Received: January 22, 2014
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Home Bound Care Transitions

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014